Agreements on information exchange

Swissmedic fosters close relationships with foreign authorities and endeavours to develop co-operation in the form of treaties. At the foreground here is the exchange of information within the entire process of authorising medicinal products, market monitoring, and the process of elaborating new regulatory provisions related to therapeutic products.

Article 64 of the Therapeutic Products Act (TPA) regulates the conditions and requirements for the provision of information by Swissmedic within the framework of international mutual administrative assistance and in general for providing information to foreign authorities. Based on this provision, Swissmedic is also authorised to request information from foreign authorities or international organisations. When exchanging data, the national provisions regarding data protection always take precedence for Swissmedic. Based on Article 64, para. 5, TPA, Swissmedic has concluded information agreements with the authorities shown in the list below.

These international agreements can take the form of legally binding agreements (state treaties) or of declarations of intent that are not legally binding. The agreements or declarations of intent have various titles. They can be called, for example, a Memorandum of Understanding (MoU), a Joint Declaration of Intent (JDI), or a Confidentiality Agreement, Arrangement or Commitment.

Country
Medicinal products authority When Type and scope of agreement Download
USA FDA 2003 Confidentiality Commitment
Therapeutic products
pdf (PDF, 209 kB, 17.09.2003)
Australia TGA 2015* MoU
Therapeutic products
pdf (PDF, 2 MB, 22.07.2015)
Chinese Taipei TFDA 2007 Exchange of Letters (EOL)
Medical devices
pdf (PDF, 473 kB, 04.07.2007)
Singapore HSA 2008 MoU
Therapeutic products
pdf (PDF, 136 kB, 12.05.2008)
New Zealand Medsafe 2009 MoU
Therapeutic products
pdf (PDF, 153 kB, 18.05.2009)
Japan MHLW / PMDA 2010 Confidentiality Arrangement
Therapeutic products
pdf (PDF, 88 kB, 01.01.2010)
Ireland HPRA 2011 MoU
Therapeutic products
pdf (PDF, 135 kB, 01.02.2011)
Germany PEI 2012 MoU
Biological medicinal products
pdf (PDF, 151 kB, 24.04.2014)
Brazil ANVISA 2012 MoU
Therapeutic products
pdf (PDF, 417 kB, 01.01.2012)
Germany BfArM 2014 Joint Declaration of Intent (JDI)
Therapeutic products (biological medicinal products within the PEI mandate)
pdf (PDF, 77 kB, 07.01.2014)
South
Korea
MFDS 2014 MoU
Therapeutic products
pdf (PDF, 72 kB, 20.01.2014)
Israel Ministry of Health 2014 JDI
Medicinal products
pdf (PDF, 112 kB, 19.05.2014)
Republic of South Africa MCC 2014 MoU
Therapeutic products
pdf (PDF, 90 kB, 12.11.2014)
China
NMPA 2015 Agreement on Cooperation in the Areas of Foodstuffs, Medicinal Products, Medical Devices and Cosmetics pdf (PDF, 169 kB, 21.01.2015)
European Union EMA 2015 EOL
Medicinal products
pdf (PDF, 489 kB, 09.07.2015)
United Kingdom MHRA 2016 MoU
Therapeutic products
pdf (PDF, 90 kB, 10.10.2016)
Mexico COFEPRIS 2016 MoU
Therapeutic products
pdf (PDF, 23 kB, 04.11.2016)
Austria AGES 2017 MoU
Therapeutic products
pdf  (PDF, 90 kB, 13.03.2017)
Netherlands MEB  2018  MoU
Therapeutic products 
pdf (PDF, 94 kB, 10.09.2018)
South Korea
MFDS 2019 Agreement on mutual reliance on inspection results of good manufacturing practice (GMP) for medicinal products pdf (PDF, 168 kB, 09.01.2020)
The United Kingdom MHRA 2019 Trade Agreement between the Swiss Confederation and the United Kingdom of Great Britain and Northern Ireland pdf (PDF, 1 MB, 21.04.2021)
Canada Health Canada 2021 Confidentiality Arrangement pdf (PDF, 371 kB, 16.04.2021)
Germany BVL 2021 Memorandum of Understanding pdf (PDF, 294 kB, 18.05.2021)

* updated Version

https://www.swissmedic.ch/content/swissmedic/en/home/ueber-uns/internationale-zusammenarbeit/bilaterale-zusammenarbeit-mit-partnerbehoerden/vereinbarung-zum-informationsaustausch.html